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IN OUR OPINION

Editorial: Finger-pointing

Published: Friday, November 16, 2012 at 6:30 a.m.

Last Modified: Thursday, November 15, 2012 at 8:06 p.m.

The indignation expressed by members of Congress during this week's committee hearings over the U.S. Food and Drug Administration's role in the nationwide meningitis outbreak would be laughable if the situation were not so tragic.

Members of the House Energy and Commerce Committee, including Ocala's own Rep. Cliff Stearns, heard testimony from FDA Commissioner Margaret Hamburg on Wednesday and chided the agency chief for failing to respond to repeated warnings about compounding lab dangers dating back to 2002.

“After a tragedy like this, the first question we all ask is, ‘Could this have been prevented?' ” asked Stearns, whose own community has been the epicenter of the meningitis epidemic that has unfolded because of inadequate regulation of compounding labs. “After an examination of the documents ... the answer here appears to be yes.”

The answer is yes. Certainly the FDA should have been more diligent in intervening at the New England Compounding Center, which is the maker of the steroid painkiller that is being blamed for the meningitis outbreak. After all, there have been complaints about the NECC's cleanliness and operating procedures going back to 2002.

Yet Congress is not blameless in all this.

Starting in 1997, when Congress first gave the FDA some regulatory authority over compounding labs, it allowed only limited power. When that authority was challenged in the courts by the industry's lobbying association, the International Academy of Compounding Pharmacists, it went to the Supreme Court, which ultimately sided with the compounding labs. After that, the agency asked Congress to establish an FDA advisory committee to oversee the compounding labs, but it was quashed by then-House Majority Leader Tom DeLay, in whose district the IACP is located.

It would be five more years before former Sen. Ted Kennedy, in whose state the NECC is located, would introduce legislation to give the FDA broader authority over compounding labs, only to once again be killed by anti-regulatory lawmakers pressured by the IACP. The legislation was opposed because it was “too broad and had the potential to disrupt the important and sometimes life-sustaining relationship between compounders and patients,” IACP spokesman David Ball told the Boston Globe last month.

Well, now 440 people have been sickened and 32 killed — including three in Marion County — by a meningitis outbreak tied to the NECC, and Congress is rightly demanding the FDA begin regulating what were once small operations that have grown into large-scale drug manufacturers.

Stearns and others, however, are grandstanding and trying to lay the blame for inaction solely at the feet of the FDA. Clearly Congress has had repeated opportunities to take necessary steps to empower the FDA to adequately protect the American people, but it has chosen instead to oppose new regulation on ideological grounds — and people are dead as a result.

As we stated previously in this column, former FDA Commissioner David Kessler warned Congress in 1996 that, left unregulated, small drug compounding outfits could morph into “a shadow industry” producing untested and unsafe drugs that “could result in serious adverse effects, including death.” Kessler was prophetic, and now it time for Congress to do what it should have done a decade and a half ago.

<p>The indignation expressed by members of Congress during this week's committee hearings over the U.S. Food and Drug Administration's role in the nationwide meningitis outbreak would be laughable if the situation were not so tragic.</p><p>Members of the House Energy and Commerce Committee, including Ocala's own Rep. Cliff Stearns, heard testimony from FDA Commissioner Margaret Hamburg on Wednesday and chided the agency chief for failing to respond to repeated warnings about compounding lab dangers dating back to 2002.</p><p>“After a tragedy like this, the first question we all ask is, 'Could this have been prevented?' ” asked Stearns, whose own community has been the epicenter of the meningitis epidemic that has unfolded because of inadequate regulation of compounding labs. “After an examination of the documents ... the answer here appears to be yes.”</p><p>The answer is yes. Certainly the FDA should have been more diligent in intervening at the New England Compounding Center, which is the maker of the steroid painkiller that is being blamed for the meningitis outbreak. After all, there have been complaints about the NECC's cleanliness and operating procedures going back to 2002.</p><p>Yet Congress is not blameless in all this.</p><p>Starting in 1997, when Congress first gave the FDA some regulatory authority over compounding labs, it allowed only limited power. When that authority was challenged in the courts by the industry's lobbying association, the International Academy of Compounding Pharmacists, it went to the Supreme Court, which ultimately sided with the compounding labs. After that, the agency asked Congress to establish an FDA advisory committee to oversee the compounding labs, but it was quashed by then-House Majority Leader Tom DeLay, in whose district the IACP is located.</p><p>It would be five more years before former Sen. Ted Kennedy, in whose state the NECC is located, would introduce legislation to give the FDA broader authority over compounding labs, only to once again be killed by anti-regulatory lawmakers pressured by the IACP. The legislation was opposed because it was “too broad and had the potential to disrupt the important and sometimes life-sustaining relationship between compounders and patients,” IACP spokesman David Ball told the Boston Globe last month.</p><p>Well, now 440 people have been sickened and 32 killed — including three in Marion County — by a meningitis outbreak tied to the NECC, and Congress is rightly demanding the FDA begin regulating what were once small operations that have grown into large-scale drug manufacturers.</p><p>Stearns and others, however, are grandstanding and trying to lay the blame for inaction solely at the feet of the FDA. Clearly Congress has had repeated opportunities to take necessary steps to empower the FDA to adequately protect the American people, but it has chosen instead to oppose new regulation on ideological grounds — and people are dead as a result.</p><p>As we stated previously in this column, former FDA Commissioner David Kessler warned Congress in 1996 that, left unregulated, small drug compounding outfits could morph into “a shadow industry” producing untested and unsafe drugs that “could result in serious adverse effects, including death.” Kessler was prophetic, and now it time for Congress to do what it should have done a decade and a half ago.</p>